Morris Plains, NJ (PRWEB) August 15, 2013
Global leader in agrochemicals will leverage Pristima Suite’s SEND module to manage the submissions in compliance with the CDISC Standard.
Xybion Corporation, The #1 Integrated Compliance, Quality, Risk & Laboratory solution for life sciences & highly regulated industries, announced that one of the world’s largest agrochemical companies has licensed the Pristima SEND module to support electronic submission of data in compliance with the CDISC Standard for Exchange of Nonclinical data.
Dr. Pradip Banerjee, Xybion Chairman & CEO was quoted, “Our clients are realizing the advantages of Xybion’s approach to automate and simplify the SEND-ready process; our approach makes Pristima an easy one-stop solution which is compelling and in line with our total preclinical solution strategy. This is a validation of our ability to deliver critical process improvement for companies operating in highly regulated industries and to deliver solutions globally.”
The Pristima Suite is an integrated set of software and solutions specifically built to support preclinical drug discovery and end-to-end preclinical process management including submission of electronic data to regulatory authorities. Pristima is used as a core preclinical platform by leading CRO’s and drug discovery and development companies worldwide.
The Pristima SEND module includes all of the components necessary to assemble and format the large volume of data in compliance with the CDISC standard and does so in the most seamless mechanism possible. The Pristima SEND module imports the raw data directly from Pristima or other sources, storing the data into a data repository and then exporting the structured data and generating the data dictionary (define.xml) file automatically through one simple process.
About Xybion Corporation:
Xybion Corporation is a global leader in the development and delivery of critical enterprise solutions to highly regulated industries, helping companies lower cost, mitigate risk and accelerate growth, while managing quality and compliance. Xybion offers a comprehensive portfolio of interconnected solutions for quality/ governance/risk/compliance, Preclinical R&D data management, Enterprise Asset Management and Enterprise Content/Records Management for clients across multiple industry sectors. Xybion compliments its product portfolio with its Global Development Center, providing broad range of professional services including validation, testing, implementation, custom application development, business intelligence, project management, training and global support. Xybion’s products and services are designed to help organizations achieve higher levels of performance, efficiency, compliance and sustained corporate governance.